AI model could predict prostate cancer spread before surgery
NCT ID NCT07112599
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is creating an artificial intelligence (AI) model that uses MRI scans and tissue samples to predict whether high-risk prostate cancer has spread to nearby lymph nodes. The goal is to help doctors make better treatment decisions without needing extra invasive tests. About 2,000 men with high-risk prostate cancer will participate to test how accurate the AI model is.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with high-risk prostate cancer (PSA ≥ 20ng/ml or Gleason ≥ 8)
- Ages
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50 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 50 years 2. Patients must have histologically or cytologically confirmed prostate adenocarcinoma 3. PSA ≥ 20ng/ml or Gleason ≥ 8 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2 5. Life expectancy ≥ 6 months 6. Normal bone marrow function: absolute neutrophil count ≥ 1.5×109/L; platelets ≥ 75×109/L; hemoglobin ≥ 90g/L; white blood cell count ≥ 3.0×109/L 7. Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); for patients with liver metastasis, ALT/AST can be ≤ 5 times ULN 8. Total bilirubin ≤ 1.5 times ULN or total bilirubin \> 1.5 times ULN and direct bilirubin ≤ ULN; 9. Normal coagulation function: International Normalized Ratio(INR) ≤ 1.5, partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) \< ULN + 4 seconds 10. Normal heart function: left ventricular ejection fraction (LVEF) ≥ 50%; corrected QT interval male \< 450ms, female \< 470ms, serum potassium ≥ 3.5mmol/L 11. Normal blood pressure: systolic blood pressure \< 140mmHg, diastolic blood pressure \< 90mmHg; patients with stable blood pressure assessment after appropriate clinical treatment can be enrolled 12. Normal renal function: serum creatinine ≤ 1.5 times ULN, and creatinine clearance ≥ 50 mL/min 13. Prospective subjects can understand and are willing to sign the informed consent form 14. Able to comply with the study visit schedule and other protocol requirements Exclusion Criteria: 1. Patients with contraindications to MRI examination, such as metal implants in the body, claustrophobia, etc. 2. Patients with any missing baseline clinical and pathological information 3. Patients with a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or seizures 4. In the judgment of the investigator, there are serious concomitant diseases that endanger the safety of the subjects or affect the subjects' completion of this study (such as severe diabetes, thyroid disease, and mental illness, etc.), or factors that affect the safety of the patients or affect the patients' provision of informed consent (including laboratory abnormalities), or any psychological, family, sociological or geographical conditions that affect the study plan and follow-up plan 5. The investigator believes that it is not suitable to participate in this clinical trial for any reason 6. Unable to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Science and Technology Institute, Anhui Medical University
RECRUITINGHefei, Anhui, 230022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Could a VR headset replace drugs for Kids' circumcision pain?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer